Method for facilitating intranasal guidance

ABSTRACT

A method for visualization and/or administration of medication of and into the sphenopalatine/pterygopalatine recess of a patient is provided. The method includes providing a sphenocath and inserting a guidewire into the nostril of a patient to a target area proximate the sphenopalatine/pterygopalatine recess of the patient. The sphenocath is advanced over the guidewire and a catheter hub of the sphenocath is rotated relative to a sheath hub to conform to an anatomy of the patient&#39;s sphenopalatine/pterygopalatine recess, such that the distal end of the catheter tube is proximal to the target area. The sphenocath is then advanced relative to a sheath assembly so that the distal end of a sphenocath catheter tube extends from a sphenocath sheath tube distal end and bends along the guidewire. The guidewire is removed and contrast media, fluids, and/or medication is administered to the patient&#39;s sphenopalatine/pterygopalatine ganglion disposed within the sphenopalatine recess of the patient.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/412,377, filed on Jan. 23, 2017; which is a divisional of U.S. patentapplication Ser. No. 14/548,860, filed on Nov. 20, 2014; which claimsthe benefit of U.S. provisional patent application Ser. No. 61/907,328,filed on Nov. 21, 2013; the entireties of which are hereby incorporatedby reference.

FIELD OF THE INVENTION

This invention relates to an apparatus and method for facilitatingintranasal guidance. More particularly, the invention relates anapparatus and method for positioning the tip of a catheter adjacent to apatient's sphenopalatine/pterygopalatine recess.

BACKGROUND OF THE INVENTION

U.S. Pat. No. 8,388,600, incorporated herein by reference, describes adevice and method of positioning a catheter tip within a patient's nasalcavity in order to deliver an anesthetic to create a nerve block. Asexplained in U.S. Pat. No. 8,388,600, FIG. 1 depicts a cutaway view ofthe anatomical features of a typical human nasal cavity. One skilled inthe art will recognize that certain anatomical features and structuresof the human nasal cavity have been omitted to avoid obscuring thestructures relevant to the practice of the current invention. To helporient the reader, the mouth 106 is illustrated with teeth 108 andtongue 110. The anatomical structures relevant to the practice of thecurrent invention include the palate 100 which separates the oral cavity102 from the nasal cavity 104, the inferior sinus turbinate 112, themiddle sinus turbinate 114 and the superior sinus turbinate 116 as wellas the nasal bone 122. The middle sinus turbinate 114 and superior sinusturbinate 116 define the sphenopalatine/pterygopalatine recess 118. Deepwithin the sphenopalatine/pterygopalatine recess 118 at the posterior124 of the sphenopalatine/pterygopalatine recess 118 lies thesphenopalatine/pterygopalatine ganglia 120.

One skilled in the art will recognize that the medical community is notuniform in the terminology with regard to the sphenopalatine orpterygopalatine ganglia. Certain practitioners use sphenopalatine whileothers use pterygopalatine. Therefore, the present description willrefer to the ganglia labeled 120 as the sphenopalatine/pterygopalatineganglia 120. Similarly, the recess labeled 118 will be referred to asthe sphenopalatine/pterygopalatine recess 118. However, this terminologyis in no way limiting on the structure for which the present inventionis intended. Where practitioners or scientist differentiate between thesphenopalatine ganglia or the pterygopalatine ganglia, the presentdisclosure will be understood to apply to either structure.

As is evident from FIG. 1, the structure of the nasal cavity makes itdifficult to deliver a catheter tip to thesphenopalatine/pterygopalatine recess 118. While U.S. Pat. No. 8,388,600describes a device and method of positioning a catheter tip, such maynot be sufficiently accurate and/or may be complicated in use.

SUMMARY OF THE INVENTION

In at least one aspect, the present invention provides an apparatus,system, and method for facilitating intranasal fluoroscopic guidance,visualization, administration of radiopaque substances, fluids, andmedication to a patient's nasal sinus including thesphenopalatine/pterygopalatine recess. The apparatus includes a wire inwhich the internal catheter tracks over the wire into the desiredlocation, and a catheter having a lumen disposed therethrough, thecatheter comprising an intrinsic curvature, soft straight proximal end,or a shape memory curvature with respect to a longitudinal axis of thecatheter such that the insertion end of the catheter lies in a firstplane and the manipulation end of the catheter lies in a second plane,wherein the catheter smoothly transitions between the wire, the firstplane and the second plane, the intrinsic curvature conforming to thewire and the patients nasal anatomy such that the catheter may beinserted into a sphenopalatine/pterygopalatine recess. The externalcatheter assists the delivery of the catheter by adding stability andpushability to the overall system allowing the internal catheter to besofter and more comfortable to the patient.

In another aspect, the invention provides a sphenocath including asheath assembly including a sheath hub with a sheath tube extendingtherefrom with a passage extending from a proximal end of the sheath hubto a distal end of the sheath tube; a catheter assembly including acatheter hub with a catheter tube extending therefrom with a passageextending from a proximal end of the catheter hub to a distal end of thecatheter tube; wherein the catheter assembly passes through the sheathassembly with a portion of the catheter hub engaging a portion of thesheath hub to limit relative rotation between the hubs while permittingrelative axial movement such that in an initial non-extended positionthe distal end of the catheter tube is proximate to the distal end ofthe sheath tube. A system further including a guidewire is alsoprovided.

In yet another aspect, the invention provides a system including asphenocath configured to be positioned over and guide into position by aguidewire.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate the presently preferredembodiments of the invention, and, together with the general descriptiongiven above and the detailed description given below, serve to explainthe features of the invention. In the drawings:

FIG. 1 is a schematic cutaway view of an exemplary facial anatomy of apatient.

FIG. 2 is a perspective view of a sphenocath in accordance with anexemplary embodiment of the invention in an initial, non-extendedposition.

FIG. 3 is a top plan view of the sphenocath of FIG. 2.

FIG. 4 is an isometric view of an exemplary catheter assembly of thesphenocath of FIG. 2.

FIG. 5 is a cross-sectional view along the line 5-5 in FIG. 4.

FIG. 6 is an elevation view along the line 6-6 in FIG. 4.

FIG. 7 is a top plan view of a portion of an exemplary sheath assemblyof the sphenocath of FIG. 2.

FIG. 8 is an elevation view along the line 8-8 in FIG. 7.

FIG. 9 is a cross-sectional view along the line 9-9 in FIG. 7.

FIG. 10 is a perspective view similar to FIG. 2 illustrating thesphenocath in an extended position.

FIG. 11 is a cross-sectional view along the line 11-11 in FIG. 10.

FIG. 12 is an elevation view along the line 12-12 in FIG. 10.

FIG. 13 illustrates the positioning of an exemplary guidewire within thenasal cavity of a patient.

FIG. 14 illustrates the positioning of the sphenocath of FIG. 2 in theinitial position as it is positioned along the guidewire.

FIG. 15 illustrates extension of the catheter from the sheath with thepatient's nasal cavity.

FIG. 16 is a side elevation view of an exemplary catheter distal end.

FIG. 17 is an end elevation view of the catheter distal end of FIG. 16.

FIG. 18 is a side elevation view of another exemplary catheter distalend.

FIG. 19 is an end elevation view of the catheter distal end of FIG. 18.

FIG. 20 is a side elevation view of another exemplary catheter distalend.

FIG. 21 is an end elevation view of the catheter distal end of FIG. 20.

DETAILED DESCRIPTION OF THE INVENTION

In the drawings, like numerals indicate like elements throughout.Certain terminology is used herein for convenience only and is not to betaken as a limitation on the present invention. The following describespreferred embodiments of the present invention. However, it should beunderstood, based on this disclosure, that the invention is not limitedby the preferred embodiments described herein.

Referring to FIGS. 2-12, a sphenocath 300 in accordance with anexemplary embodiment of the invention will be described. The sphenocath300 generally comprises a catheter assembly 310 and a sheath assembly340. As explained in more detail below, the catheter assembly 310 isconfigured to be positioned within the sheath assembly 340 and to bemoved between an initial, non-extended position as illustrated in FIG. 2and an extended position as illustrated in FIG. 10.

Referring to FIGS. 4-6, the exemplary catheter assembly 310 generallyincludes a catheter tube 330 extending from a catheter hub 312. Thecatheter hub 312 has a generally cylindrical body 314 extending betweena proximal end 311 and a distal end 313. A through passage 316 extendsthrough the body 314 from the proximal end 311 to the distal end 313.The proximal end of the passage 316 may have a larger opening 315 whichthen tapers at 317 to the diameter of the lumen 332 of the catheter tube330. The proximal end 311 of the catheter hub 312 preferably includes athread 308 or the like for connection of the catheter assembly 310 to asyringe or the like (not shown). The distal end 313 of the catheter hub312 includes a radial projection 322 configured to guide motion relativeto the sheath hub 342 as described hereinafter. The radial projection322 includes a proximal shoulder 321 and a distal tapered surface 323which facilitates passage of the catheter hub 312 into the sheath hub342. The projection 322 has a width was illustrated in FIG. 6.

Between the ends 311, 313, the catheter hub 312 includes one or moreannular rings 318 which define a gripping structure of the catheter hub312. A distal most ring 318 defines a stop 319 which limits the amountof distal movement of the catheter hub 312 relative to the sheath hub342. The catheter hub 312 is preferably manufactured from a generallyrigid material, for example, a polymer such as ISOPLAST 2510.

The catheter tube 330 extends from a proximal end 331 secured within thehub passage 316 to a free distal end 333. The catheter tube 330 ismanufactured from a flexible material, for example, a polyurethaneelastomer such as PELLETHANE. The catheter tube 330 defines a hollowlumen 332 extending from the proximal end 331 to the distal end 333 suchthat a continuous passage is defined by the catheter hub passage 316 andthe lumen 332. Referring to FIGS. 10-12, the distal end 333 of thecatheter tube 330 may be formed with a preformed curvature 335. Thecurvature 335 is such that an axis DA of the distal end 333 is at anangle relative to the axis PA of the proximal end 331. The angle ispreferably between 30 degrees to 90 degrees and more preferably isbetween 35 degrees to 55 degrees. The angle is preferably chosen tocorrespond to the anatomy of the patient's nasal cavity.

Referring to FIGS. 7-9, the exemplary sheath assembly 340 will bedescribed. The sheath assembly 340 generally includes a sheath tube 360extending from a sheath hub 342. The sheath hub 342 has a generallytubular body 344 extending between a proximal end 341 and a distal end343. A through passage 345 extends through the body 344 from theproximal end 341 to the distal end 343. The proximal end of the passage345 may have a larger opening 349 while the distal end 343 has a smallerpassage 347 which approximates the diameter of the lumen 362 of thesheath tube 360. The proximal end 341 of the catheter hub 342 preferablyincludes an annular shoulder 354 about the opening 349 which defines aninternal shoulder 356.

A guide slot 346 extends along the top surface of the sheath hub body344 from the shoulder 356 to the distal end 343. As illustrated in FIG.8, the guide slot 346 has a width W which is slightly larger than thewidth w of the catheter hub projection 322. As illustrated in FIGS. 11and 12, the distal end of the catheter hub 312 is received in thepassage 345 such that the projection 322 moves within the guide slot346. Referring to FIG. 14, contact of the projection proximal shoulder321 with the internal shoulder 356 limits proximal movement of thecatheter hub 312 relative to the sheath hub 342.

Positioning of the projection 322 in the guide slot 346 also controlsthe relative rotational movement between the hubs 312 and 342. Asillustrated in FIG. 12, the larger width W of the guide slot 346compared to the width w of the projection 322 allows for slight rotationof the catheter tube distal end 333 over a limited range, for example,approximately 10 degrees in each direction. In this way, the orientationof the preformed curvature 335 of the catheter tube distal end 333cannot be modified relative to the sheath hub 342 beyond the controlledrange.

Referring again to FIGS. 7-9, an indicator member 350 with an arrow head352 covers a portion of the guide slot 346, preferably at least over therange of axial movement of the projection 322 within the slot 346. Theindicator member 350 provides an indication of the orientation of thedevice 300 and more specifically the orientation of the preformedcurvature 335. Since, as explained above, the engagement of theprojection 322 in the guide slot 346 limits relative rotation betweenthe hubs 312, 342, the preformed curvature 335 will always be away fromthe indicator member 350. As illustrated in FIGS. 2 and 9, the indicatormember 350 may be formed with a curvature that mimics the preformedcurvature 335, i.e. away from a user looking from above and proximallyof the sheath hub 342.

The sheath tube 360 extends from a proximal end 361 secured to thesheath hub 342 to a free distal end 363. The sheath tube 360 defines ahollow lumen 362 extending from the proximal end 361 to the distal end363 such that a continuous passage is defined by the sheath hub passage345 and the lumen 362. The distal end 363 of the sheath tube 360preferably has a tapered portion 364 which provides a tapered contactsurface during advancement of the sheath tube 360 and also conforms thesheath tube diameter to that of the catheter tube 330 outer diameter.The outer surface of the sheath tube 360, preferably on the top surface,has a plurality of markers 366 which are spaced a given distance fromone another. The markers 366 can be used to illustrate a depth ofinsertion of the device, for example, the defined depth being a depthequaling a distance between an entrance to a patient's sphenopalatinerecess and an external entrance to the patient's nostril or a depthrelative to a guidewire 370 over which the sphenocath 300 is guided aswill be described hereinafter. The sheath tube 360 may also include aradiopaque mark 665 adjacent to the distal end 363 to assist withplacement of the sphenocath 300 utilizing x-ray or fluoroscopy.

The sheath tube 360 is manufactured from a semi-flexible material thatis more rigid than the catheter tube 330, but may still have someflexibility. In this way, the sheath tube 360 maintains the preformedcurvature 335 straight while within the sheath tube 360. The sheath tube360 may also be manufactured from, for example, a polyurethane elastomersuch as PELLETHANE, however, it will be a composition that provides thegreater rigidity. The sheath tube 360 may be formed with a lubricantblended with the material thereof or may be coated with a lubricant suchthat the sheath tube 360 has an external lubricious surface thatminimizes the need for additional lubricants that may irritate thetracked area.

Referring to FIG. 13, the system further includes a guidewire 370 overwhich the sphenocath 300 is guided. The guidewire 370 extends from aproximal end 374 to a distal end 372. The distal end 372 may be formedwith a preformed curvature 376 which approximates the preformedcurvature 335 of the catheter tube 330, however, it is understood thatthe curvatures may be different.

Having described the components of an exemplary system, an exemplarymethod of insertion of the catheter tube 330 into a patient's nasalcavity will be described with reference to FIGS. 13-15. First, thedistal end 372 of the guidewire 370 is inserted into the nostril 202 asillustrated in FIG. 13. Such insertion may be done, for example, usingfluoroscopic guidance or by physician feel into thesphenopalatine/pterygopalatine recess or targeted location to access.

Referring to FIG. 14, the proximal end 374 of the guidewire 370 isreceived into the catheter tube distal end 333 and the sphenocath 300 isadvanced over the guidewire 370 as indicated by arrow A. It is notedthat at this stage, the catheter hub 312 is in the initial, non-extendedposition and the distal end 333 of the catheter tube 330 is proximate tothe distal end 363 of the sheath tube 360. The sphenocath 300 isadvanced over the guidewire 370 to the desired position and location,for example, with the distal end 363 of the sheath tube 360 proximatethe anterior ridge 204 of the middle sinus turbinate 114. As explainedabove, the markings 366 may be utilized to help with the depth ofinsertion and the radiopaque mark 665 may further assist with placement.

Referring to FIG. 15, the catheter hub 312 is then advanced distallyrelative to the sheath hub 342 as indicated by arrow B. As such, thedistal end 333 of the catheter tube 330 is extended out of the distalend 363 of the sheath tube 360. The catheter tube distal end 333 followsthe path defined by the guidewire distal end 372 as indicated by arrowC. The catheter distal end 333 is advanced into the patient'ssphenopalatine/pterygopalatine recess 118 of the patient or anotherdesired position.

Once the catheter distal end 333 is positioned, the guidewire 370 isremoved and the catheter assembly 310 is ready for the desiredapplication, with a passage defined from the hub passage 316 and throughthe lumen 332. For example, a syringe or the like (not shown) may beconnected to the thread 308 and a fluid, for example, contrast media, ormedication, may be dispensed to the patient'ssphenopalatine/pterygopalatine ganglion 120 disposed within thesphenopalatine/pterygopalatine recess 118.

Referring to FIGS. 16 and 17, the configuration of an exemplary catheter310 distal end 333′ will be described. The distal end 333′ has asubstantially closed end 336 except for a slotted passage 337 extendingacross the closed end 336. The slotted passage 337 will cause fluidexpelled from the catheter 310 to fan out and provide a spraying or“painting” of the entire target area. FIGS. 18 and 19 illustrate anotherspraying tip wherein the catheter distal end 333″ has a similar slottedpassage 337, however, the closed end 336″ tapers to the passage 337,rather than the rounded end in the previous embodiment. In bothembodiments, the slotted passage 337 preferably extends horizontallyrelative to the angle of the catheter distal end 333. FIGS. 20 and 21illustrate another spraying tip wherein the catheter distal end 333′″has a substantially closed end 336 except for a series of small openings338. The openings 338 will again cause fluid expelled from the catheter310 to fan out provide a spraying or “painting” of the entire targetarea. While five openings 338 are illustrated, more or fewer openingsmay be provided and may be arranged in configurations other than theillustrated configuration.

These and other advantages of the present invention will be apparent tothose skilled in the art from the foregoing specification. Accordingly,it will be recognized by those skilled in the art that changes ormodifications may be made to the above-described embodiments withoutdeparting from the broad inventive concepts of the invention. It shouldtherefore be understood that this invention is not limited to theparticular embodiments described herein, but is intended to include allchanges and modifications that are within the scope and spirit of theinvention as defined in the claims.

1. A method for visualization and/or administration of medication of andinto the sphenopalatine/pterygopalatine recess of a patient comprising:providing a sheath assembly including a sheath hub with a sheath tubeextending therefrom with a lumen extending from a proximal end of thesheath hub to a distal end of the sheath tube, said sheath hub includinga guide slot extending along a top surface thereof, said guide slotincluding an indicator member thereon, a catheter assembly including acatheter hub with a catheter tube having a pre-formed curvatureextending therefrom, the catheter tube having a lumen therewithin, saidcatheter hub including a radially extending projection thereon, andwherein the catheter assembly is configured to be inserted into thesheath assembly such that the radially extending projection on thecatheter hub engages the guide slot to limit relative rotation betweenthe hubs while permitting relative axial movement, said guide slothaving a width larger than a width of the projection such that thecatheter hub is configured to rotate relative to the sheath hub over arotational range of approximately 10 degrees in each rotationaldirection such that the preformed curvature is always positioned awayfrom the indicator member and a distal end of the catheter tube cannotbe modified relative the sheath hub beyond a limited range; inserting aguidewire into a nostril of a patient to a target area proximate thesphenopalatine/pterygopalatine recess of the patient; advancing asphenocath over the guidewire and rotating the catheter hub relative tothe sheath hub to conform to an anatomy of the patient'ssphenopalatine/pterygopalatine recess, such that the distal end of thecatheter tube is proximate the target area; advancing the catheterassembly relative to the sheath assembly whereby the distal end of thecatheter tube extends from the sheath tube distal end; aligning thepreformed curvature of the catheter tube distal end with the patient'ssphenopalatine/pterygopalatine recess; removing the guidewire; andadministering contrast media, fluids, and/or medication to the patient'ssphenopalatine/pterygopalatine ganglion.
 2. The method of claim 1,wherein the sheath tube distal end includes a radiopaque mark and thestep of advancing the sphenocath over the guidewire includes the use ofx-ray or fluoroscopy.
 3. The method of claim 1, wherein the sheath tubeincludes a series of distance markings and the step of advancing thesphenocath over the guidewire includes advancement based on the distancemarkings.
 4. The method of claim 1 wherein the distal end of thecatheter tube includes a spraying tip and administering the contrastmedia, fluids, and/or medication to the patient'ssphenopalatine/pterygopalatine ganglion is done through the sprayingtip.
 5. The method of claim 4 wherein said spraying tip includes aslotted passage or a plurality of small opening at a substantiallyclosed end thereof.